Calcitonin,_salmon: profile and news

Nastech's Facility Approved for Commercial Manufacturing of ... Feb 28, 2006
Successful completion of this PAI enables Nastech to manufacture calcitonin-salmon nasal spray for commercial use upon FDA approval of the Company's ANDA ... - PR Newswire (press release),

FDA approves Bothell facility for making osteoporosis spray Feb 28, 2006
...announced Tuesday the successful completion of the FDA's pre-approval inspection of its Bothell facility for the manufacture of a calcitonin-salmon nasal spray ... - Puget Sound Business Journal,

Nastech site OK'd for osteoporosis spray Feb 28, 2006
The company said the Food and Drug Administration accepted its filing in February 2004 seeking approval of the generic calcitonin-salmon nasal spray. ... - United Press International

Business briefs Mar 1, 2006
Possible approval of Nastech's generic calcitonin-salmon drug has been slowed by a petition filed with the FDA that seeks to delay production of generics. ... - The Herald,

Hurdles block generic drugs Feb 13, 2006
Nastech, which focuses on developing new and reformulated nasal drugs, took a different approach with calcitonin-salmon, Miacalcin's generic name. ... - Seattle Times,

Other information

Indication
For treatment of post-menopausal osteoporosis

Pharmacology
Calcitonin inhibits bone removal by osteoclasts (bone remodeling cells) and promotes bone formation by osteoblasts. This leads to a net increase in bone mass. Calcitonin also reduces plasma calcium levels and enhances secretion of ions in the kidney.

Mechanism Of Action
Calcitonin binds to the calcitonin receptor (found primarily in osteoclasts) which then enhances the production of vitamin D producing enzymes (25-hydroxyvitamine D-24-hydroxylase), leading to greater calcium retention and enhanced bone density. Binding of calcitonin to its receptor also activates adenylyl cyclase and the phosphatidyl-inositol-calcium pathway.

Drug Category
Antihypocaclemic Agents; Antiosteporotic Agents

Brand Names/Synonyms
Calcitonin 1 precursor; Miacalcin (Novartis)

Dosage Forms
Not Available

Absorption
Not Available

Interactions
Not Available

Chemical IUPAC Name
Salmon calcitonin

Chemical Formula
C145H241N43O49S2

Half Life
Not Available

Drug Type
Approved Drug

# Accession No
BIOD00025

CAS Registry Number
12/9/9007